A Study to Assess Change in Disease State in Adult Participants With Acute Myeloid Leukemia (AML) Ineligible for Intensive Chemotherapy Receiving Oral Venetoclax Tablets in Canada (LIVEN)
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| ClinicalTrials.gov Identifier: NCT05424562 |
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Recruitment Status :
Recruiting
First Posted : June 21, 2022
Last Update Posted : May 26, 2023
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Acute Myeloid Leukemia (AML) is a cancer of the blood and bone marrow and is the most common acute leukemia in adults. This study will evaluate how well venetoclax works to treat AML in adult participants who are ineligible for intensive induction chemotherapy in Canada.
Venetoclax is a drug approved to treat Acute Myeloid Leukemia (AML). All study participants will receive Venetoclax as prescribed by their study doctor in accordance with approved local label. Adult participants with a new diagnosis of AML who are ineligible for intensive induction chemotherapy will be enrolled. Around 270 participants will be enrolled in the study in approximately 15 sites in Canada.
Participants will receive venetoclax tablets to be taken by mouth daily according to the approved local label. The duration of the study is approximately 36 months.
There is expected to be no additional burden for participants in this trial. All study visits will occur during routine clinical practice and participants will be followed for 36 months.
| Condition or disease |
|---|
| Acute Myeloid Leukemia |
| Study Type : | Observational |
| Estimated Enrollment : | 270 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Capturing Canadian Real-World Data for AML Chemotherapy Ineligible Patients on Venetoclax (LIVEN) |
| Actual Study Start Date : | September 7, 2022 |
| Estimated Primary Completion Date : | June 30, 2026 |
| Estimated Study Completion Date : | June 30, 2026 |
| Group/Cohort |
|---|
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Venetoclax Participants
Participants treated with Venetoclax in accordance with approved local label.
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- Overall Survival (OS) [ Time Frame: Up to 36 Months ]OS as defined by number of days from start of treatment to the completion of treatment or death from any cause.
- Change in Composite Complete Remission Rate [ Time Frame: Up to 36 Months ]Composite Complete Remission Rate is defined as complete remission (CR) plus complete remission with incomplete hematologic recovery (CRi) as described by the modified International Working Group (IWG) criteria.
- Event-Free Survival (EFS) [ Time Frame: Up to 36 Months ]EFS as defined by number of days from start of treatment to the date of progressive disease, relapse from CR or CRi, treatment failure or death from any cause.
- Percentage of Participants with Presence Transfusion Independence [ Time Frame: Up to 36 Months ]Transfusion Independence is defined as at least 8 and/or 16 consecutive weeks without an Red Blood Cell (RBC) or platelet transfusion during the treatment period.
- Number of Participants with Transfusions [ Time Frame: Up to 36 Months ]Number of Participants with transfusions (red blood cells and platelets).
- Number of Participants with Change in Venetoclax Dose [ Time Frame: Up to 36 Months ]Number of participants with change in venetoclax dose.
- Number of Participants with Change in Other Medications [ Time Frame: Up to 36 Months ]Number of participants with change in other medications.
- Venetoclax Administration Setting [ Time Frame: Up to 36 Months ]Venetoclax administration setting (in-patient vs. out-patient vs. at home).
- Number of Hospital Admission [ Time Frame: Up to 36 Months ]Number of hospital admission.
- Number of Participants with Change in use of Antiinfectives [ Time Frame: Up to 36 Months ]Number of participants with change in use of antiinfectives.
- Number of Participants with Change in Tumor Lysis Syndrome (TLS) Risk [ Time Frame: Up to 36 Months ]Number of participants with change in TLS risk.
- Occurrence of any Adverse Events [ Time Frame: Up to 36 Months ]An adverse event (AE) is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with their treatment as graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE).
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Diagnosis of Acute Myeloid Leukemia (AML).
- Ineligible for intensive chemotherapy, determined by the physician's assessment of age, Eastern Cooperative Oncology Group Performance Status (ECOG-PS), comorbidities, regional guidelines, and institutional practice.
- Participant for whom the physician has decided to initiate venetoclax treatment in accordance with the local label. The decision to treat with venetoclax is made by the physician prior to any decision to approach the participant to participate in this study.
Exclusion Criteria:
- Participation in an interventional clinical trial within 30 days prior to venetoclax treatment initiation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05424562
| Contact: ABBVIE CALL CENTER | 844-663-3742 | abbvieclinicaltrials@abbvie.com |
| Canada, Alberta | |
| Tom Baker Cancer Centre /ID# 248113 | Recruiting |
| Calgary, Alberta, Canada, T2N 4N2 | |
| Canada, British Columbia | |
| Vancouver General Hospital /ID# 245438 | Recruiting |
| Vancouver, British Columbia, Canada, V5Z 1M9 | |
| Canada, Manitoba | |
| CancerCare Manitoba /ID# 246414 | Recruiting |
| Winnipeg, Manitoba, Canada, R3E 0V9 | |
| Canada, New Brunswick | |
| The Moncton Hospital /ID# 247277 | Recruiting |
| Moncton, New Brunswick, Canada, E1C 6Z8 | |
| Canada, Newfoundland and Labrador | |
| Eastern Regional Health Authority /ID# 250241 | Recruiting |
| St. John's, Newfoundland and Labrador, Canada, A1B 3V6 | |
| Canada, Nova Scotia | |
| QEII - Health Sciences Centre /ID# 246514 | Recruiting |
| Halifax, Nova Scotia, Canada, B3H 2Y9 | |
| Canada, Ontario | |
| Lakeridge Health - Oshawa /ID# 246412 | Recruiting |
| Oshawa, Ontario, Canada, L1G 2B9 | |
| Thunder Bay Regional Research Institute /ID# 249163 | Recruiting |
| Thunder Bay, Ontario, Canada, P7B 6V4 | |
| Canada, Quebec | |
| Royal Victoria Hospital / McGill University Health Centre /ID# 249704 | Recruiting |
| Montreal, Quebec, Canada, H4A 3J1 | |
| CIUSSS de l'Estrie - CHUS /ID# 248915 | Recruiting |
| Sherbrooke, Quebec, Canada, J1G 2E8 | |
| Study Director: | ABBVIE INC. | AbbVie |
| Responsible Party: | AbbVie |
| ClinicalTrials.gov Identifier: | NCT05424562 |
| Other Study ID Numbers: |
P23-363 |
| First Posted: | June 21, 2022 Key Record Dates |
| Last Update Posted: | May 26, 2023 |
| Last Verified: | May 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
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Acute Myeloid Leukemia Venetoclax Venclexta |
Venclyxto ABT-199 Cancer |
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Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms by Histologic Type Neoplasms |